MAUDE Adverse Event Report: UNOMEDICAL ZAVODSKAYA STREET 50 L3C2250 - UNO OR/WOUND DRAINAGE

Model Number 13030182

Device Problem Suction Failure (4039)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/31/2022

Event Type  malfunction  

Manufacturer Narrative

Common device name: apparatus, suction, single patient use, portable, nonpowered.Procode: gcy.Complainant city: (b)(6).Patient country: (b)(6).Affiliation: (b)(6) hospital.Based on the available information, this event is deemed to be a reportable malfunction.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.Fda registration number reporting site: (b)(4).Manufacturing site: (b)(4).

Event Description

It was reported "the drainage system does not work, there is no suction from the bellow".No harm was reported.Photos depicting the reported complaint issue were provided by the complainant.

Manufacturer Narrative

Investigation details: defect wasn't confirmed by the provided picture.The issue involves 2 defective items of batch: 350304.No harm was reported with the complaints.Additional information was requested from the customer.Based on received information from the complainant the products were not used on patient, the issue was observed during testing of the bellow itself (without connecting to connector or drainage tube), a silicone ring on the bellow was presented as required, no signs of deformation or melting of the bellow were identified by customer.Affected batch: 350304 was produced in quantity of (b)(4) pcs in october 2021.The review of dhrs was performed.No ncrs related to the complaint issue were initiated during production, incoming inspection of components and batch release of product.For the production of affected batch: 350304 bellows ref: 922012.3 of batch: 500003 29.03.21 were used.According to the test-protocol 1558 dd 22/oct/2021 affected batch: 500003 29.03.21 of bellows ref: 922012.3 was accepted during incoming inspection.Also, no ncrs related to the complaint issue were identified for affected batch: 500003 29.03.21 of bellows.Manufacturing data for the affected product group universal drainage set (dhf#: 1000) was reviewed for the period from 01/jan/2019 till 01/jun/2022.Totally about (b)(4) pcs of finish goods were shipped for the analyzed period.The complaints were reviewed for the period from 01/jan/2019 till 16/jun/2022 for the presence of issues described as ¿the drainage system does not work, there is no suction from the bellow¿ product group universal drainage set (dhf#: 1000).(b)(4).Based on the medical review of the complaint, the product malfunction code was identified as ¿drn-pmc03.05 drainage collection system does not create negative pressure (e.G.Bellows do not work properly)¿.The severity of 4 was assigned by the complaint evaluation committee.No harm was reported with the complaint.(b)(4).Based on analysis of manufacturing flow, product configuration, and received information from customer following potential causes were identified, but can`t be confirmed based on available information: damage or loss of integrity of the bellows.Misuse.Based on the available information, this event is deemed to be a reportable malfunction.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.Fda registration number: reporting site: 1049092.Manufacturing site: 3007966929.

Event Description

To date no additional patient or event details have been received.

• Brand Name: L3C2250 - UNO OR/WOUND DRAINAGE
• Manufacturer (Section D): UNOMEDICAL ZAVODSKAYA STREET 50; fe unomedical ltd; minsk region; minskaya voblasts ; BO
• Manufacturer (Section G): UNOMEDICAL ZAVODSKAYA STREET 50; fe unomedical ltd; minsk region; minskaya voblasts ; BO
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC ; 3365424679
• MDR Report Key: 14684562
• MDR Text Key: 302364865
• Report Number: 3007966929-2022-00005
• Device Sequence Number: 1
• Product Code: GCY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 13030182
• Device Lot Number: 350304
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 07/05/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/30/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1